JP5805381B2 - Tools and methods for programming implantable valves - Google Patents

Description

  The present invention relates generally to a surgically implantable liquid drainage system. More particularly, the invention relates to an extracorporeal tool for reading and setting an adjustable valve used for cerebrospinal fluid drainage.

  Hydrocephalus is a neurological condition caused by abnormal accumulation of cerebrospinal fluid (CSF) in the cerebral ventricles, or cavities. Hydrocephalus affects infants, children and adults and occurs when the normal excretion of CSF in the brain is inhibited in some way. Such inhibition can be caused by a number of factors including, for example, genetic predisposition, intraventricular or intracranial hemorrhage, infection such as meningitis, or head trauma. Inhibition of CSF flow results in an imbalance between the rate at which CSF is produced by the ventricular system and the rate at which CSF is absorbed into the bloodstream. This imbalance increases pressure on the brain and dilates the ventricles. Without treatment, hydrocephalus can result in serious medical conditions, including subdural hematoma, brain cell compression, and impaired blood flow.

  Hydrocephalus is a shunt system that diverts CSF flow from the ventricle to other areas of the body, such as the right atrium, peritoneum, or other places in the body where CSF can be absorbed as part of the circulatory system. It is most often treated by surgical insertion. Various shunt systems have been developed for the treatment of hydrocephalus. Typically, the shunt system comprises a ventricular catheter, a shunt valve, and an evacuation catheter. At one end of the shunt system, the ventricular catheter is inserted through the hole in the patient's skull such that the first end is within the patient's ventricle, and typically the inlet portion of the shunt valve. Can have a second end of the ventricular catheter coupled to the. The first end of the ventricular catheter can include a plurality of holes or pores to allow the CSF to enter the shunt system. At the other end of the shunt system, the drainage catheter has a first end attached to the outlet portion of the shunt valve and allows the CSF to exit the shunt system for reabsorption into the bloodstream and into the abdominal cavity. And a second end configured to. In some shunt systems, the shunt valve is palpable through the patient's skin by the physician after implantation.

  Shunt valves can have a variety of configurations and can be designed to allow adjustment of the liquid discharge characteristics after implantation. It is generally preferred to allow external adjustment of these properties to avoid invasive surgical procedures each time adjustment is required.

  In some shunt systems, the shunt valve includes a magnetized rotor to control the pressure threshold of the valve. In such cases, the physician can use an external adjustment mechanism such as a magnetic programmer to adjust the pressure threshold of the shunt valve. One problem with magnetically programmable valves is the possibility of unintentional adjustment of the valve due to incorrect application of an external magnetic field. Unintentional adjustment of the valve can lead to either CSF over- or under-extraction, which can result in dangerous symptoms such as subdural hematoma. For example, the direction of the physical approach to the valve by a magnetic programmer that includes a strong permanent magnet, or an inappropriate initial direction of rotation of the magnetic programmer relative to the valve, may have the potential to inadvertently change the valve settings.

  It is also important that the valve settings can be read or verified externally. Some adjustable valves use X-ray images before and after adjustment to confirm the current setting of the valve. In other adjustable valves, the orientation of the rotor in the valve can be magnetically read using a magnetic compass-like device located on the valve, outside the patient's skin.

  While there are tools and methods for adjusting CSF shunt valve settings, as there are other tools and methods for reading valve settings, there is a reduced possibility of unintentional adjustment. There is a need for tools and methods that provide both an electrically programmable valve system and adjustment and verification of implantable valve settings.

  Accordingly, the present invention provides an embodiment of an integrated tool and method for externally reading and changing magnetically adjustable, implantable valve settings. In various embodiments, the valve has an outer cross section and an inner magnetic rotor. The rotor has a rotor shaft, and the rotor can be rotated by a magnetic field applied from the outside around the shaft to adjust the valve. In some valves, the applied magnetic field also releases the locking device on the rotor, and the lock functions as a safety mechanism that prevents accidental adjustment of the valve.

  One aspect of the present invention integrates the function of reading and adjusting the valve into a single tool or base that can be placed on the patient and read the valve, after which a magnet on the base is placed to place the valve. Adjust. Another aspect of the various embodiments of the present invention is a tool having a bias recess for placing the tool on or over the patient's skin above the implant valve. The bias recess has a complementary inner cross-section to mate with the outer cross-section of the valve so that the tool is positioned on the patient at a specific position relative to the valve and with a unique rotational orientation about the tool's axis of rotation To help ensure accurate reading and safe adjustment for the patient. Thus, the placement of the tool using the bias recess also aligns the rotor axis with the tool axis. In another embodiment, the bias recess is not present on the tool, but other orientation markings are provided to assist the user in positioning the tool above the valve.

  The magnet used for the adjustment of the valve may be a permanent magnet or an electromagnet that can be rotated about an axis for adjustment. Embodiments that include electromagnets for valve adjustment need to be turned off when the electromagnet is excited and not used, but embodiments that include permanent magnets for valve adjustment are also magnetic shields. Or any means for moving the magnet far enough away from the valve to prevent accidental adjustments between adjustments. In some embodiments, the permanent magnet is biased away from the valve by a spring, so that the tool needs to be pressed towards the valve to make the valve adjustment, making the magnet close enough.

  Yet another aspect of the present invention is a tool that includes a magnetic guide that more closely magnetically couples an adjusting magnet or magnetic field sensing device to a rotor. The magnetic guide allows a relatively weak magnet to be used to adjust the valve, increasing the sensitivity and accuracy of the valve reading. In some embodiments, a rotary knob is provided to rotate the magnet to adjust the valve, while in other embodiments, the adjustment is performed using a push button, which push button presses Provides incremental rotation of the adjusting magnet each time it is done. The magnet may also be rotated by a motor or other rotary device that is powered.

  Yet another aspect of the present invention is the combination of an adjustment magnet and a valve reading device in a single tool. The reader is a magnetic compass or an electronically usable magnetic sensor such as a Hall effect sensor. Electronically usable embodiments may include any type of electronic indicator that reports the current setting of the valve or guides the adjustment. The electronically usable embodiment may comprise any type of power source, including batteries and capacitors, that can be replaced or recharged by known methods.

  Yet another aspect of the invention includes an elongated tool having one end for reading a valve and the other end for adjusting a valve. Another embodiment uses a single magnet by having a position closer to the valve for adjustment and a recessed position where the magnet rotates freely and functions like a compass, Both reading and adjusting. Although embodiments of the present invention have a generally cylindrical cross-section, any shape that supports rotational adjustment of the valve can be used.

  A further aspect of the present invention is a method for reading and adjusting a magnetically readable valve from a current setting to a target setting using the integrated tool of the present invention. One embodiment of the method includes placing a tool configured for reading in the vicinity of the valve and aligning with the rotor. Generally, the tool is placed on or near the patient's skin. The current setting of the valve is read and the tool is switched to an adjustment mode in which a magnetic field from a permanent magnet or electromagnet is applied to the rotor. The magnet is then rotated and the valve is adjusted by the rotor following the rotation of the magnet.

The invention is set forth with particularity in the appended claims. The foregoing and further aspects of the present invention may be better understood by reference to the following description taken in conjunction with the accompanying drawings, in which like numerals in the various figures identify like structural elements and features. Show. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention.
1 is a cross-sectional view of an exemplary embodiment of an electronically usable integrated tool of the present invention for reading and adjusting an implantable valve. 1b is a top view of the embodiment shown in FIG. 1b is a bottom view of the embodiment shown in FIG. FIG. 2 illustrates an exemplary embodiment of the valve adjustment method of the present invention using the integrated tool of FIGS. 1a-1c. FIG. 2 illustrates an exemplary embodiment of the valve adjustment method of the present invention using the integrated tool of FIGS. 1a-1c. FIG. 2 illustrates an exemplary embodiment of the valve adjustment method of the present invention using the integrated tool of FIGS. 1a-1c. FIG. 2 illustrates an exemplary embodiment of the valve adjustment method of the present invention using the integrated tool of FIGS. 1a-1c. FIG. 2 schematically illustrates an exemplary embodiment of a dual-ended integrated tool for reading and adjusting a magnetically adjustable valve and the method of the present invention. FIG. 2 schematically illustrates an exemplary embodiment of a dual-ended integrated tool for reading and adjusting a magnetically adjustable valve and the method of the present invention. FIG. 2 schematically illustrates an exemplary embodiment of a dual-ended integrated tool for reading and adjusting a magnetically adjustable valve and the method of the present invention. FIG. 2 schematically illustrates an exemplary embodiment of a dual-ended integrated tool for reading and adjusting a magnetically adjustable valve and the method of the present invention. FIG. 2 schematically illustrates an exemplary embodiment of a dual-ended integrated tool for reading and adjusting a magnetically adjustable valve and the method of the present invention. FIG. 2 schematically illustrates an exemplary embodiment of a dual-ended integrated tool for reading and adjusting a magnetically adjustable valve and the method of the present invention. 3a is a cross-sectional view of an exemplary mechanically implemented embodiment of the dual end tool of FIGS. 3a-3f. FIG. 3a is a cross-sectional view of an exemplary mechanically implemented embodiment of the dual end tool of FIGS. 3a-3f. FIG. 4b is a cut-away perspective view of the read end of one embodiment of the tool shown in FIGS. 4a and 4b. FIG. 4b is a cut-away perspective view of the read end of one embodiment of the tool shown in FIGS. 4a and 4b. FIG. 1 is an external view of an exemplary electronically implemented embodiment of a dual end integrated tool of the present invention. FIG. 1 is a cross-sectional view of an exemplary electronically implemented embodiment of a dual end integrated tool of the present invention. FIG. FIG. 6 schematically illustrates an exemplary embodiment of a method for reading and adjusting a magnetically adjustable valve using the dual end tool of FIGS. 6a and 6b. FIG. 6 schematically illustrates an exemplary embodiment of a method for reading and adjusting a magnetically adjustable valve using the dual end tool of FIGS. 6a and 6b. FIG. 6 schematically illustrates an exemplary embodiment of a method for reading and adjusting a magnetically adjustable valve using the dual end tool of FIGS. 6a and 6b. FIG. 6 schematically illustrates an exemplary embodiment of a method for reading and adjusting a magnetically adjustable valve using the dual end tool of FIGS. 6a and 6b. FIG. 3 is an external perspective view of an exemplary embodiment of a function-integrated integrated tool of the present invention for reading and adjusting a magnetically adjustable valve. FIG. 6 is a bottom view of an exemplary embodiment of the present integrated function integrated tool for reading and adjusting a magnetically adjustable valve. FIG. 9 is a cross-sectional functional block diagram of the tool of FIGS. 8a and 8b and an exemplary method for reading and adjusting a magnetically adjustable valve. FIG. 9 is a cross-sectional functional block diagram of the tool of FIGS. 8a and 8b and an exemplary method for reading and adjusting a magnetically adjustable valve. FIG. 9 is a cross-sectional functional block diagram of the tool of FIGS. 8a and 8b and an exemplary method for reading and adjusting a magnetically adjustable valve. FIG. 9 schematically illustrates an exemplary embodiment of a magnetic drum component of a tool of the type shown in FIGS. 8-9c. FIG. 9 is an exploded view of the internal components of an exemplary embodiment of a tool of the type shown in FIGS. 8-9c. The figure which shows the partial assembly of the component shown in FIG. The figure which shows the partial assembly of the component shown in FIG. FIG. 14 shows details of an incremental rotation adjustment process using a tool of the type shown in FIGS. 8a-13. FIG. 14 shows details of an incremental rotation adjustment process using a tool of the type shown in FIGS. 8a-13. FIG. 14 shows details of an incremental rotation adjustment process using a tool of the type shown in FIGS. 8a-13. FIG. 14 shows details of an incremental rotation adjustment process using a tool of the type shown in FIGS. 8a-13. FIG. 4 is a cross-sectional view of an exemplary embodiment of a two-part tool of the present invention for reading and adjusting a magnetically adjustable valve. FIG. 4 is a cross-sectional view of an exemplary embodiment of a two-part tool of the present invention for reading and adjusting a magnetically adjustable valve. FIG. 16 is a top view of the two-part tool shown in FIGS. 15a-15b.

  The method and integrated tool of the present invention consistently and reliably reads an implantable, magnetically configurable valve (valve) using an integral adjustment and reading tool by a physician. It is possible to change (adjust) the setting from the current setting to the target setting. In an exemplary embodiment, the valve is used to control at least one of a CSF discharge flow and discharge pressure of a hydrocephalus patient via a valve setting and is embedded under the patient's scalp or other portion of the skin. It can also be adjusted from outside (upper) of the patient's skin.

  Another tool and method for reading and adjusting hydrocephalus valves from outside the body is a co-pending US patent application entitled “Tools and Methods for Programming an Implantable Valve”, which is incorporated herein by reference in its entirety. No. 12 / 415,590. Within the scope of the present invention, the features of the various embodiments disclosed herein may be used in any combination to constitute an additional integrated tool and method for implantable valve reading and adjustment. be able to.

  The hydrocephalus valve that is read and adjusted by the tools and methods of the present invention comprises a magnetic rotor, and the rotational orientation of the rotor about the rotor axis indicates the current setting of the valve and is used to modify the setting. A magnetic field applied from the outside can be used to adjust the valve to the target setting by rotating the rotor about the rotor axis. In addition, some hydrocephalus valves contain a locking element to prevent accidental adjustment of the valve due to stray magnetic fields, and prior to rotating the rotor about the rotor axis, a magnetic field for valve adjustment is applied. The valve must be unlocked by applying along the rotor shaft.

  Any means of applying a magnetic field to adjust the valve or sensing the orientation of the rotor to read the valve can be incorporated into the tools and methods of the present invention. In some embodiments, the externally applied magnetic field for valve adjustment is provided using one or more permanent magnets that can be physically oriented about the rotor axis. In another embodiment, the externally applied magnetic field for valve adjustment is provided using one or more electromagnets having a magnetic field that can be electronically or physically oriented about the rotor axis.

  Reading the current setting of the valve is accomplished by sensing the rotational orientation of the magnetic rotor about the rotor axis. In some embodiments, rotational orientation sensing is achieved using a magnetically sensitive mechanical device such as a magnetic compass. In another embodiment, rotational orientation sensing is achieved using one or more Hall effect sensors that are solid state electronic devices capable of measuring magnetic fields.

  In yet another embodiment, rotational orientation sensing is incorporated into the valve and is capable of reporting one or both of the valve position and orientation in response to an externally applied radio frequency (RF) signal. This is accomplished using electromagnetic communication with a device such as an automatic identification (RFID) microelectronic device. Some embodiments that include electronic components further comprise an electronic display that can indicate the current setting of the valve, notification of valve adjustment completion, or other aspects of the tool status. In addition, various embodiments include a ferromagnetic component that provides one or both of shielding the sensitive component from the magnetic field and guiding the magnetic field to the desired location.

  Referring to the drawings in more detail, FIG. 1 a shows the electronically usable of the present invention for both reading and adjusting a magnetically adjustable valve 102 implanted directly under a patient's skin 104. An embodiment of the integrated tool 100 is schematically shown in cross section. The valve 102 includes a magnetic rotor 106 having a rotor shaft 108, and the rotor 106 rotates by application of a magnetic field around the shaft to adjust the valve 102. In one embodiment, the valve 102 has a predetermined plurality of settings corresponding to a predetermined plurality of rotational orientations of the rotor 106 about the rotor shaft 108. In one embodiment, the plurality of settings includes eight settings.

  It should be understood that the valve 102 may be any magnetically configurable, implantable valve with a magnetically rotatable rotor, and further includes a magnetically unlockable valve. . In one embodiment, the valve 102 is unlocked for rotation about the rotor axis 108 by movement along the rotor axis 108 of the rotor, and the movement is provided by applying an attractive magnetic field along the rotor axis 108. Is done. In a further embodiment, the attractive magnetic field and the magnetic field for rotation of the rotor about the rotor axis are provided by a single magnetic source, which can be either a permanent magnet or an electromagnet.

  The integrated tool 100 is illustrated as comprising a substantially cylindrical outer shell 110 having an upper end 112, a lower end 114, and a longitudinal tool axis 116 extending therebetween. In various other exemplary embodiments of the tools disclosed herein, the expression “substantially cylindrical” is used for illustration and includes any structure that does not functionally interfere with the tool. It should be noted that it is intended to include an outer cross section, for example other geometric cross sections.

  The knob 118 is shown extending longitudinally from the upper end 112 of the shell 110. The knob 118 is rotatable relative to the shell 110 about the tool axis 116 and is shown with a plurality of rotational position markings 120 referenced to reference marks 122 on the outer surface 124 of the shell 110. . In an alternative embodiment, the reference mark is on the surface of the knob 118 and the plurality of rotational position markings are on the surface of the shell 110.

  In one embodiment, the knob 118 includes eight rotational position markings 120 that correspond to the eight available settings of the valve 102. The shell 110 is illustrated as comprising a central portion 126 that is substantially tubular about the tool axis 116 and a lower portion 128 that includes a bias recess 130. FIGS. 1 b and 1 c schematically show an external top view 132 and a bottom view 134 of the integrated tool 100, respectively.

  It can be seen that the bias recess 130 is preferably configured to be palpable through the patient's skin so that the shape is complementary to engage the valve 102. As used herein, the term “bias” refers to a non-cylindrical cross-section that allows the bias recess 130 to be positioned to engage the skin 104 above the implant valve 102, at a predetermined location and tool on the skin 104. Used to indicate having only in a specific direction of rotation about axis 116. Thus, positioning the shell 110 above the valve 102 causes the tool shaft 116 to align with the rotor shaft 108. In one embodiment, the palpable shape closely corresponds to the manufactured shape of the valve 102, which may be any of a variety of shapes depending on the particular design and function of the valve 102.

  In another embodiment, rotational orientation of the shell 110 about the tool axis 116 is indicated by one or more orientation markings 132 on the outer surface 134 of the lower portion 128 of the shell 110. In a further embodiment (not shown), there is no bias recess 130 on the shell 110 and one or more orientation markings 132 provide the main guide for orienting the shell 110 on the patient's skin 104. To do.

  The knob 118 is illustrated as being mechanically connected to a read and adjustment assembly 136 that is rotatably disposed within the shell 110 such that the knob 118 is associated with the shell 110 about the tool axis 116. When rotated, the entire read and adjust assembly 136 rotates with the knob via the mechanical linkage 138. The read and adjust assembly 136 includes an electromagnet 140 having a core 142, a magnetic guide 144 extending from the core 142 toward the lower end 114, and a power source 146 that can supply power to the electromagnet 140 via an electronic control unit 148. In one embodiment, the power source 146 is a battery. In one embodiment, the magnetic guide 144 comprises a ferromagnetic material. 2a-2d, in another embodiment, the power source 146 is a supercapacitor. In yet another embodiment, the power source 146 can be inductively recharged by a charger (not shown) external to the integrated tool 100 using known methods for inductive charging.

  The read and adjust assembly 136 further includes one or more Hall effect sensors 150 mounted in the vicinity of the electromagnet 140. In another embodiment, the read and adjust assembly 136 comprises one or more other types of magnetic sensors. One or more Hall effect sensors 150 are coupled via an electronic control unit 148 to an electric indicator 152 disposed on the outer surface of the integrated tool 100. In various embodiments, the indicator 152 is an electrically excited light emitter or sound emitter. In one embodiment, the indicator 152 is a light emitting diode disposed on the knob 118. In another embodiment, one or more Hall effect sensors are mounted on the magnetic guide 144.

  A power switch 154 for turning the electronic control unit on and off and an excitation switch 156 for turning the electromagnet 140 on and off are electrically connected to the read and adjust assembly 136. In one embodiment, one or both of the switches 154, 156 are attached to the shell 110. In another embodiment, one or both of the switches are attached to the knob 118. In one embodiment, the excitation switch 156 is a momentary contact switch that turns off the electromagnet 140 when released.

  With the integrated tool 100 positioned on the valve 102, the power switch 154 is turned on and the excitation switch 156 is turned off to activate one or more Hall effect sensors 150 and associated portions of the control unit 148. The magnetic guide 144 senses the magnetic field of the rotor 106 and the magnetic guide enhances the magnetic coupling between the rotor 106 and one or more Hall effect sensors 150. The sensed magnetic field depends on the rotational orientation of knob 118 via the orientation of the corresponding read and adjust assembly 136.

  An exemplary embodiment of how to use the integrated tool 100 to read and adjust the magnetic valve 102 is schematically illustrated in FIGS. 2a-2d. For purposes of illustration in FIGS. 2a-2d, the reference mark 122 is shown in a different rotational position on the shell 110 than that shown in FIGS. 1a-1c. In the illustrated embodiment, the indicator 152 is a light emitting diode. 2a-2d are external views and the internal components of the integrated tool 100 are not shown.

  As shown in FIG. 2 a, the integrated tool 100 arranged to engage on the valve 102 is actuated using a power switch 154. The knob 118 is then rotated until the orientation of the rotor 106 is sensed by one or more Hall effect sensors 150, and in this rotation shown in FIG. 2b as position "2" aligned with the reference mark 122, the indicator 152 is lit to report the current setting of the valve to the user. Referring now to FIG. 2c, the excitation switch 156 is then actuated and held to unlock the rotor 106. FIG. The knob 118 is then rotated to the target setting and the rotor 106 follows the rotation of the electromagnet 140.

  The magnetic guide 144 enhances the coupling between the magnetic field of the electromagnet 140 and the rotor 106 to minimize the power required for the electromagnet to unlock the rotor 106 and rotate the rotor. In one embodiment, the indicator 152 remains activated while the electromagnet 140 is energized. In another embodiment, the operation of the electromagnet 140 is displayed to the user as a change in the output of the indicator 152. Once the target setting shown as position “4” in FIG. 2d is obtained, the excitation switch 156 is released to stop the electromagnet 140 and the power switch 154 is turned off to complete the adjustment procedure. In one embodiment, the power switch 154 is automatically turned off by the control unit 148 after a predetermined period of non-use to save energy stored by the power source 146.

  The electronically usable integrated tool 100 has several advantages. As a single tool, there are no separable components that can be misplaced or accidentally separated from the tool. In addition, the reading and adjustment of the implanted valve is accomplished without moving the tool once the tool is placed on the valve, thereby improving patient comfort and use during the procedure or multiple tools or tool Reduce the possibility of operator error related to relocation. While the use of an electromagnet that can be activated and deactivated as needed prevents the valve from being adjusted incorrectly, the strong permanent magnet used to adjust the valve is carefully oriented or magnetized as the magnet approaches the valve. Need to be shielded to reduce the possibility of accidental adjustments. In addition, the coupling of the electromagnet to the valve via the magnetic guide minimizes the electromagnet power requirements. In addition, a single magnetic guide is used to provide a foundation for the construction of a tightly integrated, highly functional tool by enhancing magnetic coupling to both the sensor and electromagnet valve rotors.

  Also advantageously, determining the current setting of the valve using a Hall effect sensor or other type of electronic sensor makes the tool completely independent of the orientation relative to the Earth's gravitational field, so that the tool can be in any orientation. Can be used. Hall effect sensors that do not have moving parts are also advantageous in the use of magnetic sensing with weak permanent magnets, such as physically relatively fragile compass needles, which weak magnetic fields are used to adjust valves. It also has a magnetization that can be changed under the influence of a strong magnetic field such as.

  FIGS. 3 a-3 f schematically illustrate an embodiment of a double-ended integrated tool 200 and a method for reading and adjusting a magnetically adjustable valve 102 implanted under a patient's skin 104. Shown in Referring to FIG. 3a, the dual end tool 200 includes a substantially cylindrical body 202 having a read end 204, an adjustment end 206, and a tool axis 208 therebetween. For reading the valve 102, the user of the dual end tool 200 aligns the read end 204 with the valve 102 in the read orientation, as shown in FIGS. For adjustment of the valve 102, the user reverses the ends of the double end tool 200 to align the adjustment end 206 with the valve 102 as shown in FIGS. 3d-3f. In one embodiment, the reading end 204 and the adjusting end 206 are used independently of each other to read and adjust the valve 102, respectively. In another embodiment, reading the current setting of the valve using the reading end 204 programs the adjusting end 206 to the current reading of the valve 102.

  Referring to FIGS. 3 a-3 c, the reading end 204 may be one or more readings that rotationally orient the dual end tool 200 about the tool axis 208 relative to the valve 102 prior to reading the valve 102. Illustrated with an orientation marking 210. It can be seen that the read end 204 also includes a read button 212 and a display 214 that displays the current setting of the valve 102. In one embodiment, the read button 212 is an electrical switch that activates an array of Hall effect sensors mounted in the vicinity of the read end 204 by turning on the electronics in the dual end tool 200. The rotational orientation of the rotor 106 about the rotor axis 116 is read using a Hall effect sensor and reported on the display 214. In one embodiment, the array of Hall effect sensors is a circumferential array that detects the orientation of the rotor 106 without having to rotate the dual end tool 200 about the tool axis 208. In one embodiment, the number of Hall effect sensors is equal to the number of available valve settings in valve 102. In another embodiment, other types of magnetic field sensors are used to sense the magnetic field of the rotor 106 and read the valve 102.

  In yet another embodiment, the read button 212, when activated, is centered on the tool axis 208 of the compass-type magnetic field detector mounted in the read end 204 in response to the magnetic field of the rotor 106. A mechanical release that allows free rotation. In this embodiment, the current reading of the valve 102 is maintained when the read button 212 is released and can continue to be viewed in the display 214. In one embodiment, the compass detector includes a plurality of marker markings 216 so that only one marking can be viewed in the display 214 at a time. In one embodiment, the plurality of circumferential markings 216 comprises eight markings corresponding to the eight available settings of the valve.

  With reference to FIGS. 3 d-3 f, the adjusting end 206 is illustrated as comprising a sleeve 218 around the body 202, which is longitudinally beyond the body 202 on the opposite side of the reading end 204. It has an end portion 220 that extends. The sleeve 218 includes one or more adjuster orientation markings 222 for rotationally aligning the double end tool 200 above the valve 102, the alignment being visible or palpable through the patient's skin 104. As such, it is guided by the physical profile of the valve. In another embodiment, the termination 220 includes a bias recess that has a configuration similar to and functions similarly to the bias recess 130 of the integrated tool 100. The surface of the body 202 that is longitudinally adjacent to the sleeve 218 is shown with a plurality of rotational position markings 224. In one embodiment, the plurality of rotational position markings 224 comprises eight markings corresponding to the eight available settings of the valve 102.

  Sleeve 218 is rotatable relative to body 202 about tool axis 208. Alternatively, to select one of the plurality of rotational position markings 224 relative to one of the one or more adjuster orientation markings 222, the body 202 can be moved within the sleeve 218 with the tool axis 208. You may rotate as a center. The sleeve 218 is also axially spring loaded relative to the body 202 so that the body 202 is longitudinally moved when the dual end tool 200 is pressed against the skin 104 as shown in FIGS. 3e and 3f. Slide into the sleeve 218 to shorten the overall length of the double end tool 200.

  4a and 4b schematically show cross-sectional views of an exemplary embodiment of a mechanically implemented dual end tool 200. FIG. First, referring to the reading end 204, also shown in the cut-away partial perspective views of FIGS. 5a and 5b, the two-end tool 200 is magnetically coupled to a marker ring 228 having a plurality of circumferential markings 230. Illustrated with a compass 226. In one embodiment, only one of the plurality of markings 230 corresponding to the current orientation of the compass 226 can be viewed on the display 214 at a time (as shown in FIGS. 3a-3f). With the read button 212 depressed, as shown in FIGS. 4a and 5b, the compass 226 is moved when the read end 204 is moved closer to and aligned with the rotor shaft 116 as shown in FIGS. 3a-3c. In addition, it rotates freely around the tool axis 208 in response to an external magnetic field. When the reading button 212 is released (released), the mechanical brake 232 is engaged to prevent rotation of the compass 226 about the tool axis 208, as shown in FIGS. 4a and 5a.

  In the following, referring to the adjusting end 206 shown in FIGS. 4 a and 4 b, one or more magnets 234 are fixed inside the body 202, and the magnet attracts the rotor 106 when the valve 102 is approached to pull the valve 102. It is effective to adjust. As shown in FIG. 4 a, one or more magnets 234 are shown recessed from the end portion 220. In one embodiment, a magnetic shield 236 is disposed between the one or more magnets 234 and the compass 226 at the reading end 204 to shield the compass 226 from the magnetic field of the one or more magnets 234. In a further embodiment, the magnetic shield 236 is made from a ferromagnetic material.

  One or more magnets 234 in the recessed position shown in FIG. 4a are not effective in adjusting the valve 102 when the valve 102 is positioned axially adjacent to or beyond the end portion 220. As shown in FIG. The sleeve 218 is shown to include a spring 238 that biases the sleeve 218 to extend longitudinally from the body 202, as shown in FIG. 4a. For example, by pressing the tool axially against the skin 104 on the valve 102, the axial force applied to the sleeve 218 at the end 220 will cause the sleeve 218 to slide over the body 202 as shown in FIG. 4b. (In other words, sliding the body 202 into the sleeve 218), compressing the spring 238, and bringing one or more magnets 234 closer to the termination 220, and the valve 102 terminating axially When arranged adjacent to the portion 220, it is effective for adjusting the valve 102. In one embodiment, the spring 238 provides sufficient axial force to prevent accidental sliding associated with the body 202 of the sleeve 218, but may cause damage to the patient's skin 104 or significant discomfort. It is adapted to apply forces that are not sufficient to occur. In another embodiment, there is no sleeve 218 to prevent unintentional adjustment of the valve 102; instead, a ferromagnetic shield is placed over the adjustment end and the shield is one or more magnets 234. The rotor 106 is shielded from the one or more magnets 234 until it is physically moved or rotated away from between it and the rotor 106.

  FIGS. 3 a-3 f show an embodiment of a method of using the double end tool 200 for reading and adjusting the valve 102. In FIG. 3 a, the read end 204 of the dual end tool 200 is illustrated as being positioned above the valve 102 and guided by one or more read orientation markings 210, the markings being observable through the skin 104. It is rotationally aligned with a predetermined structure of the valve 102. In one embodiment, the predetermined structure is a visual profile of one or more of a valve inlet, a valve 102 outlet, and the valve itself. For the mechanically implemented dual end tool 200 embodiment, the display 214 displays the valve setting when the read button 212 was last activated.

  Referring now to FIG. 3b, the read button 212 is activated for reading the valve 102, and the current setting of the valve 102 is shown in the display 214 (shown as setting “2” in FIGS. 3b-3e). ing). Once the current setting has been read, the read button 212 is released and the sleeve 218 is rotated relative to the body 202 about the tool axis 208 as shown in FIG. 3c to provide multiple rotations corresponding to the current setting of the valve. One of the position markings 224 is aligned with one of the one or more regulator orientation markings 222. In one embodiment, the dual end tool 200 includes a plurality of circumferential detents between the sleeve 218 and the body 202 such that one of the plurality of rotational position markings 224 is one or more adjusters. A positive indication is provided that indicates alignment with one of the orientation markings 222. Next, referring to FIG. 3 d in which the regulator end 206 has been rotated to the current setting of the valve 102, the double end tool 200 has been rotated vertically to position the adjustment end 206 above the valve 102, And guided by one or more regulator orientation markings 222 and rotationally aligned with a predetermined structure of the valve 102 in a manner similar to that performed for reading the valve 102, with the body 202 and sleeve 218 as a unit. To do.

  Referring to FIG. 3e, the dual end tool 200 is axially pressed against the patient's skin 104 on the valve 102 to physically bring one or more magnets 234 into the valve 102, thereby providing one or more. The magnet 234 is effective for adjusting the valve 102 by magnetically attracting the rotor 106. In one embodiment, the valve 102 is also unlocked for adjustment by the proximity of one or more magnets 234. Finally, referring to FIG. 3f, adjustment of the valve 102 can be accomplished by rotating the body 202 about the tool axis 208 within the sleeve 218 to select one of a plurality of rotational position markings 224 corresponding to the target setting of the valve 102. This is accomplished by matching one (shown as setting “2” in FIG. 3 f) to one of the one or more regulator orientation markings 222.

  FIGS. 6a and 6b schematically illustrate an exterior view and a cross-sectional view, respectively, of an exemplary embodiment of the dual end tool 250 of the present invention that is performed electronically. An embodiment of the electronically implemented dual end tool 250 is illustrated to be generally similar to the dual end tool 200 disclosed hereinabove, but the valve is made using electronic technology and automation. Adapted to read and set 102. Referring first to FIG. 6a, an electronically implemented dual end tool 250 is illustrated as comprising a substantially cylindrical body 252 that includes a read end 254, an adjustment end 256, and those With a longitudinal tool axis 258 in between.

  The read end 254 is illustrated as including one or more read orientation markings 260 having a position and function similar to the read orientation marking 210 associated with the dual end tool 200 disclosed hereinabove. Yes. The main body 252 is illustrated as being mounted with a setting ring 262 that is rotatable about the main body 252 for entering a target setting for the valve 102 referenced to a reference marking 264 on the main body 252. The body 252 also includes an electronic display 268 that displays the current settings of the valve 102 and a start switch 270 that initiates the reading and adjustment procedure. In alternative embodiments, other electronic input devices are provided that may include a thumbwheel instead of setting ring 262, one or more electronic switches mounted on body 252 or any other electronic input device. The In a further embodiment, the electronic display 268 displays the target setting in addition to the current setting of the valve 102.

  The adjusting end 256 is the same as that disclosed in connection with FIGS. 4a and 5a, except that the sleeve 272 shown in FIGS. 6a and 6b is not rotatable relative to the body 252 about the tool axis 258. Illustrated with a sleeve 272 that is biased in the same manner as the sleeve 218 associated with the heavy end tool 200 and extends longitudinally from the distal end of the body 252. The sleeve 272 includes one or more adjuster orientation markings 274 having a position and function similar to the one or more adjuster orientation markings 222 associated with the dual end tool 200 disclosed hereinabove. Is shown in FIG. In one embodiment, the bias is provided by a compression spring 276 disposed between the body 252 and the sleeve 272. As shown in FIG. 6 b, a magnetic assembly 278 is present within the body 252 and is mounted for rotation about the tool axis 258 within the body 252, when the assembly is approached to the valve 102. One or more magnets 280 are provided that are effective to attract the rotor 106 and adjust the valve 102.

  In one embodiment, the electronically implemented dual end tool 250 also includes an electric motor 282, which is powered by a power source that may be a battery, supercapacitor, or another power source. It is useful to rotate the magnetic assembly 278 about the tool axis 258 under the control of 284. In one embodiment, the power supply 286 is inductively rechargeable by a charger (not shown) external to the electronically implemented dual end tool 250. In another embodiment, the magnetic assembly 278 includes one or more electromagnets that can be excited by the power source 286 via the control circuit 284. The electronic control circuit 284 also controls an array of magnetic sensors 288, which in one embodiment includes a plurality of Hall effect sensors as disclosed above with respect to the dual end tool 200. In a further embodiment, the motor 282 is coupled to the magnetic assembly 278 via a rotary linkage 290, which in one embodiment includes a reduction in rotational speed from the motor 282 to the magnetic assembly 278.

  FIGS. 7 a-7 d schematically illustrate an exemplary embodiment of an electronically implemented dual end tool 250 usage for reading and adjusting the valve 102. 7a-7d are external views of an electronically implemented dual end tool 250, the internal components of the tool being described with reference to FIGS. 6a and 6b. Referring now to FIG. 7a, the read end 254 is in the same manner as disclosed above in connection with FIG. 3a for aligning the read end 204 of the dual end tool 200 with respect to the valve 102. To the valve 102. The setting ring 262 is rotated at any time during the procedure to indicate the desired target setting of the valve 102. The setting ring 262 can be set to the target setting at any time during the reading and adjustment procedure.

  Referring now to FIG. 7 b, the start switch 270 is engaged to read the current setting of the valve 102 by the array of magnetic sensors 288 and display the current setting on the display 268. In addition, similar to the procedure disclosed above in connection with FIG. 3d with respect to the double-ended tool 200, the electronically-executed double-ended tool 250 rotates longitudinally so that the adjusting end is as shown in FIG. 7c. When aligned with the valve 102, the motor 282 is automatically actuated under the control of the electronic control circuit 284 to rotate the magnetic assembly 278 within the body 252 so that the current setting of the valve 102 is adjusted to the regulator orientation marking 274. Is matched in relation to

  Moving from FIG. 7c to FIG. 7d, similar to the process disclosed above in connection with FIG. 3e with respect to the double end tool 200, the electronically executed double end tool 250 is pressed against the patient's skin 104, The valve 102 is adjusted by bringing the magnetic assembly 278 physically close to the valve 102 and magnetically attracting the rotor 106. In one embodiment, when the sleeve 272 is pressed against the skin 104, the motor 282 automatically starts and rotates the magnetic assembly 278 to manually rotate the body 252 within the sleeve 272 about the tool axis 258. Adjust the valve to the target setting without. In another embodiment, the display 268 is updated to indicate the target setting when the adjustment is complete.

  Advantageously, the double-ended tool disclosed above is a single tool that does not have separable components that can be misplaced or accidentally separated from the tool. In addition, the reading and adjusting parts of the tool are physically isolated from each other at the opposite ends of the tool and are magnetically shielded from each other so that the adjusting magnet can affect the compass reading of the valve Minimize sex. Further, in one embodiment, valve readings can be maintained indefinitely using a compass reader without using any power. In an electronically implemented embodiment, the reading and adjusting procedure can be greatly automated to further reduce the possibility of inaccurate reading or adjustment, increasing patient safety and comfort. Also, in an electronic embodiment, an electronic magnetic field sensor, such as a Hall effect sensor, can eliminate interference between the reading and adjusting functions of the valve.

  Also advantageously, the double-ended tool can be configured to have a physically small diameter, providing a small physical profile on the patient's skin, and so on, such as near the patient's ear. This provides additional convenience in situations where it is embedded in a location where access for reading and adjustment can be difficult. In one embodiment, the double-ended tool is configured as a pen-shaped instrument that medical professionals can conveniently carry, for example, in a pocket of a laboratory lab coat. In a further embodiment, the double end tool includes a pocket clip to prevent loss during carrying of the tool.

  One embodiment of an integrated function integrated tool 300 for reading and setting the valve 102 is shown in an external perspective view in FIG. 8a and a bottom view in FIG. 8b. The function integration tool 300 is illustrated as comprising a substantially cylindrical upper portion 302 having an upper end 304, a substantially cylindrical lower portion 306 having a lower end 308, and a common longitudinal tool axis 310. Yes. The upper portion 302 and the lower portion 306 are slidably coupled to each other along the axis 310, and the lower portion 306 is slidable within the upper portion 302, and thus between the upper portion 302 and the lower portion 306. An axial compressive force can reversibly slide the lower portion 306 further into the upper portion 302.

  In one embodiment, the compression counters the internal spring bias of the function integration tool 300. In another embodiment, the upper portion 302 is slidable within the lower portion 306. In one embodiment, sliding the upper portion 302 and the lower portion 306 together further causes the function integration tool 300 to move from the valve reading mode when extended to the tool axis 310 to the tool axis 310. Switch to the valve adjustment mode when compressed to maximum along.

  The upper portion 302 is shown with a rotary advance button 312 extending axially from the upper end 304. The rotary advance button 312 is adapted to adjust the valve 102 when the function integration tool 300 is in the valve adjustment mode. In one embodiment, the upper portion 302 also includes a clip 314 that releasably secures the function integration tool 300 to a garment pocket or other object. The lower portion 306 is shown with a window 316 for viewing the current setting of the valve 102. In one embodiment, an indication of whether the function integration tool 300 is in a reading mode or an adjustment mode is also visible in the window 316.

  The lower portion 306 is also illustrated with a bias recess 318 at the lower end 308, which is preferably adapted to have a complementary shape to engage the valve 102 so that it can be palpated through the patient's skin 104. ing. A bias recess 318 having a shape and function similar to the bias recess 130 disclosed in connection with FIG. 1 a with respect to the integrated tool 100 is provided on the skin 104 so that it engages on the skin 104 above the implant valve 102. It has a non-circular cross-section that can be placed only in position and in the inherent rotational orientation of the function integration tool 300 about the tool axis 310.

  9a-9c schematically illustrate a cross-sectional functional block diagram of an exemplary embodiment of a function integration tool 300 and an exemplary method for reading and adjusting a valve 102. FIG. In FIGS. 9 a-9 c, the function integration tool 300 is illustrated as being disposed on the skin 104 above the valve 102 with the tool shaft 310 aligned with the valve shaft 108. The bias recess 318 is not shown in FIGS. 9a-9c. Referring first to FIG. 9 a, the function integration tool 300 includes a reading module 320 and an adjustment module 322 therein, and the reading module and the adjustment module are separated from each other by an annular disk 324 fixed in the upper portion 302. It is shown as follows. The annular disk 324 is shown with a central opening 326 through which the first rotational locking member 328 extends toward the adjustment module 322. The adjustment module 322 is illustrated as including a second rotational locking member 330 that is complementary to the first rotational locking member 328. The first rotation fixing member 328 and the second rotation fixing member 330 are axially engageable with each other and rotationally couple the adjustment module 322 to the reading module 320 as shown in FIG. 9c.

  Referring to FIG. 9 a, the function integration tool 300 is shown in a read mode, extended to the maximum along the tool axis 310. The reading module 320 is illustrated as including a substantially cylindrical drum 332 that is freely rotatable about the tool axis 310 when in reading mode. The drum 332 includes one or more magnets 334 that rotate the freely rotatable drum 332 about the tool axis 310 under the influence of the magnetic field of the rotor 106 in the valve 102, and the magnetic compass In a manner, the drum 332 is illustrated as being arranged to read the current setting of the valve 102 by rotationally aligning it with the rotor 106. The one or more magnets 334 include a magnetic field that is strong enough to adjust the valve 102 when approached against the valve 102 in the axial direction in the adjustment mode shown in FIGS. 9b and 9c. In read mode, the drum 332 is spaced from the valve 102 along the tool axis 310, as shown in FIG. 9a, and longer distances in the read mode are weaker between one or more magnets 334 and the rotor 106. Providing magnetic interaction, thereby preventing one or more magnets 334 from unlocking or adjusting the valve 102.

  In one embodiment, the outer surface 336 of the drum 332 includes a plurality of first circumferential indicators 338 corresponding to a plurality of available valve 102 settings, as shown in FIG. One of them is visible through a window 316 as shown in FIG. In a further embodiment, the drum 332 includes a second circumferential plurality of markings 340 corresponding to a plurality of available valve 102 settings. In one embodiment, the second plurality of indicators 340 are longitudinally displaced from the first plurality of indicators 338 by a distance equal to the axial travel distance of the drum 332 between the reading mode and the adjustment mode. Thus, in the reading mode, one of the first plurality of signs 338 is visible through the window 316, and in the adjustment mode, the corresponding one of the second plurality of signs 340 is displayed in the window 316. Is visible through. In one embodiment, both the first plurality of indicators 338 and the second plurality of indicators 340 include numbers, and the first plurality of indicators 338 and the second plurality of indicators 340 are distinguishable from each other by color. It is. In a further embodiment, the first plurality of indicators 338 are black and the second plurality of indicators 340 are red.

  When compressive force is applied to the function integration tool 300 by pressing the upper portion 304 toward the valve 102, the function integration tool 300 switches from the reading mode to the adjustment mode, as shown in FIG. 9b. In the adjustment mode, the drum 332 is shown being moved closer to the rotor 106 compared to the reading mode to allow adjustment of the valve 102. In one embodiment, in the adjustment mode, the one or more magnets 334 also unlock the rotor 106 to allow adjustment of the valve 102.

  The adjustment module 322 includes a forward button 312 that adjusts by moving the second rotational fixing member 330 axially when pressed axially into the upper portion 302 as shown in FIG. 9c. It can be seen that the module 322 is rotationally fixed with respect to the reading module 320. In one embodiment, the adjustment module 322 is biased toward the upper end 304 by a button return spring 342. Further, when the advance button 312 is depressed, the adjustment module 322 and the reading module 320 to which the rotary advance assembly 344 is rotationally fixed are rotated together as a unit about the tool axis 310 to cause the valve 102 to rotate. Incrementally adjust from the current setting to the next adjacent setting of valve 102.

  In one embodiment, the rotary advancement assembly 344 includes a plurality of stable rotational positions corresponding to a plurality of valve settings. In one embodiment, the rotary advancement assembly 344 comprises eight stable rotational positions, which together include a 360 ° rotation. The rotary advancement assembly 344 can use any type of incremental rotary advancement that provides a rotation step consistent with available valve settings. In one embodiment, the rotary advancement assembly 344 includes a sawtooth cylindrical gear 346 having a plurality of teeth 348. In one embodiment, the plurality of teeth comprises eight teeth 348, and each push and release cycle of the advance button 312 includes a rotationally fixed reading module 320 and an adjustment module 322, with the tool axis 310 as the center. In connection with portion 302, it is rotated by 1/8 (45 °) of full rotation, thereby adjusting valve 102 by one incremental setting. In one embodiment, when the advance button 312 is pressed, the beveled end 350 of one or more teeth 348 slides against the other surface of the rotary advance assembly 344 to drive rotation.

  FIG. 11 illustrates an exemplary embodiment of the components of the reading module 320 and the adjustment module 322 in a collective exploded view. In this embodiment, a rotary coupling 352 is shown adjacent to the advance button 312 and the serrated gear 346 along the tool axis 310, the rotational coupling 352 comprising a central cylindrical body 354, a coupling A tool flange 356 and a plurality of transverse pins 358 are provided, each pin being adapted to be slidably received between adjacent teeth 348 of the serrated gear 346. The rotary coupler 352 is a second rotary locking member 330 that can engage the first rotary locking member 238 when the button return spring 342 is compressed and the function integration tool 300 is in the (compressed) adjustment mode. Is further provided. The advance button 312 and the sawtooth gear are illustrated as being biased apart axially by a biasing spring 360.

  The drum 332 is illustrated as being rotatably and slidably disposed on a bearing base 360 that is secured to the inner surface of the lower portion 306 of the function integration tool 300. A plurality of circumferential signs 338, 340 are not shown in FIG. The first rotational locking member 328 is partially slidable within the drum 332, but is illustrated as being rotationally coupled to the drum. The drum 332, the bearing base 362, and the first rotation fixing member 328 are illustrated as being biased away along the tool axis 310. In one embodiment, the drum 332, the bearing base 362, and the first rotation locking member 328 are biased apart by first and second compression springs 364, 366.

  12 and 13 show a partial assembly of the components shown in FIG. FIG. 12 shows the upper partial assembly with a rotary coupling 352 disposed axially adjacent to the first rotational locking member 328 and fitted with an advance button 312 and a serrated gear 346. FIG. 13 shows the lower partial assembly, in which the first rotational locking member 328 and the bearing base 362 engage the drum 332 in the axial direction via corresponding springs 364, 366 so that the bearing base 362 and the annular disk 324 are engaged. It is shown that the drum 332 is attached so as to rotate freely.

  The rotary coupler 352 is rotatable about the tool axis 310 within the upper portion 302, while the advance button 312 and the serrated gear 346 are not rotatable. Each of the plurality of pins 358 has an outer end 368 that is adapted to fit within one of a plurality of molded receiving notches 370 circumferentially disposed about the inner periphery of the upper portion. Has been. Incremental rotational adjustment using the rotary advancement assembly 344 is functionally illustrated in FIGS. 14a-14d, where the plurality of teeth 348 portions are associated with the corresponding plurality of pins 358 portions. It is shown as being coupled to a portion of the receiving notch 370. For purposes of explanation, each of the components shown in FIGS. 14a-14d is depicted in plan view rather than in a circumferential view, and the horizontal translation of FIGS. 14a-14d is performed within the function integration tool 300. Corresponds to rotation.

  FIG. 14a shows the start of a valve adjustment cycle that moves the plurality of teeth 348 downward in FIG. 14a as the forward button 312 is pressed. As the plurality of teeth 368 move downward, each pin 358 and thus the rotary coupler 252 is first pushed vertically downward along the vertical portion 372 of the corresponding notch 370, thereby causing the first 328 and The second rotation fixing member 330 is engaged with each other, and the adjustment module 322 is rotationally coupled to the reading module 320 to adjust the valve 102. Referring now to FIG. 14b, as the plurality of teeth 348 continue to move downward, each pin 358 moves downward along the sloped portion 374 of the corresponding notch 370 to rotate with the rotary coupler 252, and thus rotationally. The entire fixed reading and adjusting module is rotated about the tool axis 310.

  At the bottom of the movement of the plurality of teeth 348, as shown in FIG. 14c, each pin 358 passes rotationally through the bottom portion 376 of the corresponding notch 358, thus the advance button 312 is released and the plurality of As the teeth return upward, each pin 358 moves along the upper sloped portion 378 of the notch next to the corresponding notch 370 and rotates until it reaches the next vertical portion 380, as shown in FIG. 14d. The tool 252 is continuously rotated about the tool axis 310, and each pin moves vertically in the next vertical portion, and the first rotation fixing member 328 and the second rotation fixing member 330 are separated to perform an adjustment cycle. Complete. In one embodiment in which the plurality of teeth comprises eight teeth, each push and release cycle of the advance button 312 results in a 45 ° rotation corresponding to an incremental adjustment of one of the eight valve settings.

  The use of the function integration tool 300 for reading and adjusting the valve 102 is shown in FIGS. 9a-9c. FIG. 9 a shows a function integration tool positioned above and aligned with valve 102 in reading mode, where drum 332 rotates freely about tool axis 310 to read valve 102 and window 316. The current setting is displayed (shown in FIG. 8a). Referring now to FIG. 9b, it can be seen that the function integration tool 300 is axially compressed and in adjustment mode, with the drum 332 now in close proximity to the valve and the magnetic force between one or more magnets 334 and the rotor 106. The coupling is increased so that the valve can be adjusted. In one embodiment, the valve is unlocked for adjustment as one or more magnets 334 approach the rotor 106 in the axial direction.

  Referring now to FIG. 9c, it is illustrated that the advance button is pressed, rotationally coupling the reading module 320 and adjustment module 322, and further rotating the coupled module to increase the valve setting. Adjust the valve. After the valve setting is increased, the adjustment process of FIG. 9c may be repeated until the required valve adjustment is complete, and the tool is removed from its position above the valve 102.

  The integrated function integrated tool 300 has several advantages. As an integrated tool, the implantable valve can be read and adjusted with a single tool. The function integration tool 300 also has a read mode as a spring-biased default configuration, which prevents incorrect adjustment of the valve by placing an adjustment magnet in a location recessed from the end of the tool. In addition, the tool can be used to read and adjust the valve once the tool is placed on the patient without the need to move the tool, reducing the possibility of any user error and reducing patient safety. And increase comfort. Further advantageously, the function integration tool 300 comprises a single magnetic assembly to both read and adjust the valve, eliminating the possibility of any interference between the read magnet and the adjustment magnet.

  FIGS. 15 a and 15 b schematically show in cross-section an exemplary embodiment of the two-part tool 400 of the present invention for reading and adjusting the valve 102. The two-part tool 400 includes a base 402, a rotatable core 404 that can rotate about the tool axis 406 substantially within the base 402, and a separable adjusting magnet 408 that can be releasably attached to the rotatable core 404. It is shown as comprising. FIG. 15a shows the two-part tool 400 in read mode with the adjustment magnet 408 separated from the rotatable core 404, and FIG. 15b shows the adjustment with the adjustment magnet 408 attached to the rotatable core 404. A two-part tool 400 in mode is shown.

  The base 402 is shown with a bias recess 410 that has a complementary shape to engage the valve 102 and is preferably adapted to be palpable through the patient's skin 104. A bias recess 410 having a form and function similar to the bias recess 130 disclosed in connection with FIG. 1 a with respect to the integrated tool 100 is provided on the skin 104 so that it engages on the skin 104 above the implant valve 102. It has a non-circular cross-section that can be placed only in position and in the inherent rotational orientation of the two-part tool 400 about the tool axis 406.

  It can be seen that the rotatable core 404 has an upper surface 412 and a lower surface 414, and the upper surface 412 receives the adjusting magnet 408 in a predetermined orientation relative to the rotatable core 404 about the tool axis 406. And is adapted to hold releasably. The rotatable core 404 can also be seen to include a magnetic compass 416 for reading the current setting of the valve 102, which can be read from the top surface 412. The compass 416 is mechanically fixed to rotation to read the valve 102 by default, and further includes a release button 418 that releases the compass 416 to read the current setting of the valve 102 when mechanically pressed. Prepare. In another embodiment, the one or more magnetic sensors for reading the current setting of the valve 102, the rotatable core 404, further comprises a power source and an electronic display visible at the top surface 412.

  The rotatable core 404 also includes one or more magnetic guides 420 that provide magnetic coupling between the upper surface 412, the lower surface 414, and the compass 416. In one embodiment, the one or more magnetic guides 420 comprise a ferromagnetic material. In the reading mode shown in FIG. 15a, one or more magnetic guides 420 magnetically couple the compass 416 to the rotor 106 while the release button 418 is depressed, and the compass 416 is capable of sensing the orientation of the rotor 106. And thereby improve the ability to read valve settings. In the adjustment mode shown in FIG. 15 b, the adjustment magnet 408 is illustrated as being disposed on the upper surface 412 and is coupled to the rotor 106 via one or more magnetic guides 420. While the compass 416 is mechanically fixed (the release button 418 is not pressed), its reading is not affected by the presence of the adjustment magnet 408.

  Due to the presence of the magnetic guide 420, a magnet that is weaker than that required in the absence of the magnetic guide 420 can be used as the adjusting magnet 408, thereby leading to the rotatable core 403 before and after valve adjustment. Or the risk of accidental adjustment of the valve 102 when physically moved away from the rotatable core 403 is reduced.

  FIG. 16 schematically shows a top view of the two-part tool 400 in the adjustment mode, where the adjustment magnet 408 is mounted on a core 404 that is rotatable over one or more magnetic guides 420 and is magnetically coupled to the guides. Is bound to. In one embodiment, adjustment magnet 408 and upper surface 412 cause adjustment magnet 408 to be disposed on the upper surface only in a single predetermined rotational orientation about tool axis 406 at a single predetermined position. It has a complementary physical structure.

  The base 402 is shown to include one or more tool alignment markings 422 that indicate an orientation for placing the two-part tool 400 on the patient's skin 104 above the valve 102. Base 402 is shown to further include a plurality of circumferential marking markings 424 corresponding to a plurality of available valve settings. In one embodiment, the plurality of marker markings 424 comprises eight markings. The rotatable core 414 has a reference marking 426 indicating one of a plurality of marker markings 424 selected by a rotational orientation relative to the base 402 about the tool axis 406 of the rotatable core 404. It is shown as comprising.

  Referring to FIGS. 15 a-16, in an exemplary procedure for reading and adjusting the valve 102 using the two-part tool 400, the base 412, away from the alignment magnet 108, is initially the patient above the valve 102. Is shown as being placed and aligned on the skin 104 of the skin. The release button 418 is then pressed to release the compass 416 and the current setting of the valve 102 is read. The rotatable core 404 is manually rotated about the tool axis 406 to align the reference marking 426 with one of a plurality of marker markings 424 indicated by a compass reading, such as the current setting of the valve 102. .

  Referring now to FIG. 15 b, the adjustment magnet 408 is illustrated as being attached to the upper surface 412 of the rotatable core 404. In one embodiment, attachment of the adjustment magnet 408 to the rotatable core 404 unlocks the valve 102. The rotatable core 404 is then rotated about the tool axis 406 to the target setting of the valve 102. Next, the adjusting magnet 408 is removed from the rotatable core. In one embodiment, the adjustment is then confirmed by pressing the release button 418 again and reading the new setting of the valve 102.

  The two part tool 400 has several advantages. By using a magnetic guide to couple the adjusting magnet and the valve rotor, it is possible to use a relatively weak magnet that would not be required for adjusting the valve. The relatively weak adjustment magnet reduces the possibility of unintentional adjustment of the valve and allows for a lighter and more portable reading and adjustment tool configuration. In addition, since the coupling between the adjusting magnet and the magnetic guide is very strongly dependent on their separation distance, the adjusting magnet does not significantly affect the rotor until it is contacted with the magnetic guide.

  The magnetic guide in the two-part tool also advantageously reduces the dependence of the compass operation on the compass orientation relative to the earth's magnetic field by providing a close magnetic coupling between the rotor and the compass. In some embodiments, the magnetic field of the rotor is electronically sensed and a combination of magnetic guides and compass is provided to provide a tool that is more mechanically and magnetically stronger than already provided tools. provide.

  Advantageously, embodiments of the tools and methods of the present invention provide a means for smoothly integrating the reading, adjustment, and confirmation of embedded valve settings in a simple, repeatable procedure. In addition, embodiments of the present invention allow for implantable valve readings and adjustments to targeted settings with reduced risk of inadvertent or inaccurate adjustment of the valve. By reducing the risk of misadjustment, patient comfort and safety are improved, which is an excess of CSF where improper adjustment can result in dangerous symptoms such as subdural hematoma This is because it can lead to either emissions or under-emissions.

  Although the invention has been particularly shown and described with reference to certain preferred embodiments, those skilled in the art will understand the form and details without departing from the spirit and scope of the invention as defined by the appended claims. It should be understood that various changes can be made.

Embodiment
(1) A magnetically readable and configurable tool for reading and changing the current setting of a valve embedded in a living organism,
A substantially cylindrical body, the body having an upper end, a lower end, a longitudinal axis between the upper end and the lower end, and an axis along at least a portion of the body between the upper end and the lower end A body having a directional hole, the lower end being positionable near the valve above the patient's skin;
A magnet disposed in the hole and having a first axial position close to the lower end and a second axial position recessed from the lower end,
The magnet in the second position is freely rotatable about the longitudinal axis for reading of the valve;
A tool wherein the magnet in the first position is adapted to change the current setting of the valve.
(2) further comprising a bias recess at the lower end, the bias recess having a complementary inner cross-section so as to engage with the outer cross-section of the bulb, and having a unique rotational orientation about the longitudinal axis; Embodiment 2. The tool of embodiment 1 adapted to be placed in the vicinity of the valve.
(3) further comprising a push button biased to extend substantially axially from the upper end, wherein the push button has a pressing and releasing cycle associated with the upper end in the axial direction centered on the longitudinal axis. 2. The tool of embodiment 1, wherein the tool causes a predetermined angle of rotation of the magnet.
(4) The embodiment wherein the valve includes a plurality of settings corresponding to a plurality of equal rotation increments about the longitudinal axis and the predetermined angle includes one of the plurality of rotation increments. 2. The tool according to 2.
5. The tool of embodiment 3, wherein the plurality of equal rotation increments is eight increments including a complete rotation about the longitudinal axis.
(6) A method of reading and adjusting a magnetically readable and adjustable valve from a current setting to a target setting, wherein the valve is implanted under the skin of a patient, the method comprising:
Providing a tool comprising a magnet having a first position in the tool for adjustment of the valve and a second position in the tool for reading the valve; The tool has a tool axis, and the magnet is rotatable about the tool axis;
Placing the tool near the valve above the patient's skin;
Reading the current setting of the valve with the magnet in the second position;
Moving the magnet from the second position to the first position;
Adjusting the valve from the current setting to the target setting by rotating the magnet in the first position about the axis.
7. The method of embodiment 6, wherein adjusting the valve by rotating the magnet about the axis includes rotating the valve substantially by a predetermined 45 degrees.
(8) The tool comprises a bias recess, the bias recess having a complementary inner cross section to engage the outer cross section of the valve so that it can be palpated through the patient's skin, 7. The method of embodiment 6, wherein disposing near the valve above the skin comprises disposing the bias recess to engage the valve near the patient's skin.

Claims (5)

A magnetically readable and configurable tool for reading and changing the current setting of a valve embedded in a living organism,
A substantially cylindrical body, the body having an upper end, a lower end, a longitudinal axis between the upper end and the lower end, and an axis along at least a portion of the body between the upper end and the lower end A body having a directional hole, the lower end being positionable near the valve above the patient's skin;
A single magnet disposed in the hole and having a first axial position close to the lower end and a second axial position recessed from the lower end;
The single magnet in the second position is freely rotatable about the longitudinal axis for reading of the valve;
The single magnet in the first position is adapted to change the current setting of the valve ;
The valve includes a rotatable magnetic rotor, and a sensor for detecting the orientation of the magnetic rotor is fixed to the single magnet, and the single magnet is in the second position when the single magnet is in the second position. A tool in which one magnet rotates and the sensor detects the orientation of the magnetic rotor .   Further comprising a bias recess at the lower end, the bias recess having a complementary inner cross-section to engage the outer cross-section of the bulb, and in the vicinity of the bulb in a unique rotational orientation about the longitudinal axis The tool according to claim 1, adapted to be placed on the tool.   A push button biased to extend substantially axially from the upper end, wherein a push and release cycle associated with the upper end of the push button in the axial direction is centered about the longitudinal axis; The tool according to claim 1, wherein the rotation of the magnet is caused by a predetermined angle. Wherein the valve comprises a plurality of settings corresponding to a plurality of equal rotational increments around the said longitudinal axis, said predetermined angle comprises one of the plurality of rotational increments, according to claim 3 Tools. The tool of claim 4 , wherein the plurality of equal rotation increments is eight increments including a full rotation about the longitudinal axis.

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